Engineer - Complaints

Orthofix•Lewisville, TX

About The Position

Why Orthofix? Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech. Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further. How you'll make a difference? In this role, you have the opportunity to evaluate, investigate, and resolve complaints while also analyzing complaint data and gathering additional information as needed. You will manage the complaint investigation process end-to-end. You will work with other teams in a collaborative environment to complete the end-to-end complaints process in a highly regulated environment.

Requirements

BS in engineering discipline or equivalent education, experience, training.
3+ years of experience in a medically regulated and technical environment.
Experience with electrical components and/or medical device software is a plus.
Demonstrated strong results orientation.
Proficiency using statistical tools, office tools, and various other computer software applications.
Must be able to work under pressure to meet regulatory reporting time frames and company requirements.
Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.
Requires the proven ability to consistently meet and/or exceed goals.
Must be capable of making commitments, setting priorities, and delivering results on time.

Responsibilities

Evaluate, investigate, track and complete complaints through effective and established complaint handling process.
Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
Collaborate with Engineering, Customer Support, Field personnel, and other appropriate groups for adequate initial evaluation of complaints.
Participate and collaborate objectively with productive conclusions in the Complaint Handling Unit meetings.
Coordinate with the reportable complaint investigators in providing any missing information for root cause activities.
Collaborate with Complaint Handling Unit for reportable complaints as well as CAPA Review Board for Correction and Removal process.
Assist in trending of complaints and collaborate with the appropriate groups to ensure that the data gets pushed to the appropriate departments for actions.
Support reviews and audits assigned.
Identify and drive process related improvements related to compliance and efficiency gains
Work with the Complaint Handling Supervisor for any other projects assigned.